News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Sure Genomics Offering $2,500 Whole Human Genome Profile to Consumers, but ‘Doctor Prescribed’ Medical Laboratory Test Caught the Attention of the FDA

FDA sends letter to the California-based start-up concerning clearance for SureDNA test kit before accepting pre-orders from consumers

Competition to market whole-human genome sequencing to consumers is heating up. Not only is the Food and Drug Administration (FDA) watching these developments, but it is taking action to regulate companies that offer direct-to-consumer whole-human genome sequencing in developments that should be watched by clinical laboratory managers and pathologists.

One example is Sure Genomics. It claims to be breaking barriers by offering a $2,500 at-home whole human genome test to consumers.

The company believed the new test kit, called SureDNA, would escape FDA restrictions on the direct sale of health reports to consumers. However, the FDA’s recent letter to the California-based startup indicates Sure Genomics may face the same regulatory roadblocks that have stymied other direct-to-consumer genetic testing companies. (more…)

Group Health Cooperative Study Uses EHRs and Stepped Interventions to Double Rate of Colorectal Cancer Screenings

Pathologists and clinical laboratory managers may find new opportunities to increase testing volumes as patients’electronic health records yield clinically relevant data

Sophisticated use of electronic health records (EHRs), automated reminder systems, and telephone follow-up can double cancer-screening compliance by consumers. That could mean an increase in testing volumes for clinical laboratories serving clinics using this approach.

Researchers at the Group Health Research Institute (GHRI) used electronic health records to identify Group Health Cooperative (GHC) patients who weren’t screened regularly for cancer of the colon and rectum.

Because of how EHRs were used to step-up patient compliance for cancer screening, the study findings may be useful for pathologists and clinical laboratory managers. Over the years, many medical laboratories have furnished referring physicians a list of their patients who are due for screening tests, such as for cervical cancer. (more…)

Two U.S. Studies Show Home-based Hospital Care Lowers Costs while Improving Outcomes and Patient Satisfaction

Studies show home-based hospital acute care results in fewer medical laboratory and diagnostic tests

Home-based hospital care (HBHC) is a care delivery model that is evolving at a rapid pace. To be effective, HBHC must improve patient outcomes while avoiding the expenses associated with an inpatient stay at a hospital.

However, significant growth in the number of patients treated in home-based hospital care programs would directly affect hospital-based clinical laboratories and pathology groups. Among other things, this would reduce the volume of inpatient testing while increasing the number of outpatient/outreach specimens.

Evidence is accumulating in favor of HBHC. New research shows that a New Mexico home-based hospital care (HH) program demonstrated cost savings and equal or better patient outcomes and patient satisfaction for acutely-ill patients compared to similar patients receiving in-hospital care. These new findings affirm similar results from a 2005 study of HBHC. (more…)

Two Studies Find that Patients Want Access to their Health Records, Including Clinical Pathology Test Data

Patients are ready to ready access to their medical records; but physicians are wary

Data from two studies here in the United States affirms that patients want access to their health records. Consequently, health systems are increasingly making it easier for patients to get access to prescription lists, medical laboratory test results and now even doctors’ notes.

These findings are important for clinical laboratories and anatomic pathology groups. Laboratory test data typically makes up 70% of the information contained in patient’s health record. The growing interest on the part of patients to have access to their health records creates an opportunity for labs to add value by helping patients have access to their laboratory test results.

Of course, in providing that access, labs must comply with applicable laws governing patient privacy. They must also respect the relationship patients have with referring physicians and how those physicians are themselves allowing patients access to the health records they maintain in their medical practices.

New Diagnostic Technology Creates Opportunities for Clinical Laboratories to Help Physicians with Faster, More Accurate Diagnoses

Using monoclonal and polyclonal antibodies to detect only human blood in stool, this technology compares favorably when tested against other methodologies

New diagnostic technologies are literally tumbling out of research laboratories and biotech development companies at an increasing pace. The sheer volume of proprietary medical laboratory tests and new molecular diagnostic assays makes it a challenge for pathologists and clinical laboratory managers to identify which new lab tests have the greatest clinical value—and will also be adequately reimbursed by payers.

Each time a clinical laboratory wants to bring up a new medical laboratory test, it requires substantial effort. The laboratory will expend substantial financial, clinical, and operational resources to acquire the instrumentation, run the studies needed to validate the test, and begin the process of educating physicians about the value of the new test and how to use it in their medical practice. (more…)